Randomized Controlled Trial of Vaginal Cryotherapy for Pelvic Floor Myofascial Pain

Abstract Background Post-fistula-repair incontinence (PFRI) is a common complication of vesicovaginal fistula (VVF) surgeries. It entails continuous leakage of urine after successful VVF closure. Pelvic Floor Muscle Training (PFMT) plays a vital role in the management of PFRI, however, an evolving exercise approach is the Paula Exercise Method (PEM) which has shown a promising effect in stopping urinary incontinence, but there is no data on its effect on PFRI. This study therefore, proposes to primarily investigate the effect of PEM on urine leakage and secondarily, pelvic floor strength (PFS), quality of life (QoL), sexual function (SF), and mental health (MH) in women with PFRI. Methods This is a study protocol for a randomized controlled trial. A total of 182 participants are expected to participate in the study after satisfying the inclusion criteria. The participants will be randomized into either PEM or PFMT study groups. The demographic data of all the participants will be recorded. Each participant will be assessed for urine leakage, PFS, QoL, SF, and MH at baseline and subsequently, at four, eight and 12 weeks of intervention. Demographic parameters will be summarized using descriptive statistics. Continuous data will be computed for differences using inferential statistic of Analysis of variance, t-test and Man Whitney U as appropriate. All analyses will be performed using SPSS version 22.0 with probability set at 0.05 alpha level. Discussion It is hoped that the outcome of this study will determine the effect of the Paula exercise method on urine leakage, pelvic floor strength, quality of life, sexual function, and mental health among women with post-fistula-repair incontinence and also provide evidence for the use of the Paula method in urinary incontinence. Trial registration: Pan African Clinical Trials Registry (www.pactr.org), identifier PACTR201906515532827.

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Re: Assessment of levator hiatal area using 3D / 4D transperineal ultrasound in women with deep infiltrating endometriosis and superficial dyspareunia treated with pelvic floor muscle physiotherapy: randomized controlled trial

Ultrasound in Obstetrics and Gynecology ◽

10.1002/uog.23636 ◽

2021 ◽

Vol 57 (5) ◽

pp. 849-849

Author(s):

M. Hirsch ◽

J. M. N. Duffy ◽

C. M. Farquhar ◽

Keyword(s):

Randomized Controlled Trial ◽

Pelvic Floor ◽

Pelvic Floor Muscle ◽

Controlled Trial ◽

Transperineal Ultrasound ◽

Deep Infiltrating Endometriosis ◽

Randomized Controlled ◽

Hiatal Area ◽

Infiltrating Endometriosis

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Assessment of pelvic floor muscles with 3D/4D transperineal ultrasound in women with deep infiltrating endometriosis and superficial dyspareunia treated with pelvic floor muscle physiotherapy: a randomized controlled trial

Ultrasound in Obstetrics and Gynecology ◽

10.1002/uog.23590 ◽

2021 ◽

Author(s):

S. Del Forno ◽

A. Arena ◽

V. Pellizzone ◽

J. Lenzi ◽

D. Raimondo ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Pelvic Floor ◽

Pelvic Floor Muscle ◽

Controlled Trial ◽

Pelvic Floor Muscles ◽

Transperineal Ultrasound ◽

Deep Infiltrating Endometriosis ◽

Randomized Controlled ◽

Infiltrating Endometriosis

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Re: Can Pelvic Floor Muscle Training Reverse Pelvic Organ Prolapse and Reduce Prolapse Symptoms? An Assessor-Blinded, Randomized, Controlled Trial

The Journal of Urology ◽

10.1016/s0022-5347(11)60301-7 ◽

2011 ◽

Vol 185 (4) ◽

pp. 1383-1383

Author(s):

David F. Penson

Keyword(s):

Randomized Controlled Trial ◽

Pelvic Organ Prolapse ◽

Pelvic Floor ◽

Pelvic Floor Muscle Training ◽

Pelvic Floor Muscle ◽

Controlled Trial ◽

Pelvic Organ ◽

Muscle Training ◽

Randomized Controlled ◽

Prolapse Symptoms

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The Therapeutic Effects of Acupuncture on Patients with Chronic Neck Myofascial Pain Syndrome: A Single-Blind Randomized Controlled Trial

The American Journal of Chinese Medicine ◽

10.1142/s0192415x10008299 ◽

2010 ◽

Vol 38 (05) ◽

pp. 849-859 ◽

Cited By ~ 29

Author(s):

Mei-Yuan Sun ◽

Ching-Liang Hsieh ◽

Yung-Yen Cheng ◽

Hung-Chang Hung ◽

Tsai-Chung Li ◽

...

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Myofascial Pain ◽

Short Form ◽

Controlled Trial ◽

Pain Syndrome ◽

Myofascial Pain Syndrome ◽

Randomized Controlled ◽

Single Blind

Chronic neck myofascial pain syndrome (MPS) is a common disorder seen in clinics. There is no gold standard method to treat myofascial pain. We investigated the effects of acupuncture on patients with chronic neck MPS by a single-blind randomized controlled trial. A total of 35 patients were randomly allocated to an acupuncture group (AG) or a sham acupuncture group (SG). Each subject received acupuncture treatment twice per week for three consecutive weeks. The primary outcome measure was quality of life as assessed with Short Form-36, and secondary outcome measures were neck range of motion (ROM), motion-related pain, and Short-Form McGill Pain Questionnaire (SF-MPQ), as determined by a blinded investigator. The clinical assessments were made before treatment (BT) and after six acupuncture treatments (AT), as well as four weeks (F1) and 12 weeks (F2) after the end of the treatment. A total of 34 patients completed the trial. The results indicated that there is no significant difference in the ROM, motion-related pain, and SF-MPQ scores between AG and SG at AT, F1 and F2 (all p > 0.05). However, AG has greater improvement in physical functioning and role emotional of Short Form-36 quality of life at F2. The results indicate that acupuncture may be used to improve the quality of life in patients with chronic neck MPS.

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